State Court Consolidation

A Definitive Opioid Crisis Solutions Event

By Mark A. York (May 29, 2018)

(MASS TORT NEXUS MEDIA) It’s been called the most perilous drug crisis ever in the United States, the epicenter of the opioid epidemic, overdose deaths have quadrupled since 1999, killing more than 100 people every day. Pharmaceutical opiate pain relief is an essential clinical tool, but with physicians writing over 240 million opioid prescriptions to Americans every year, the potential for catastrophe is enormous. Now it seems to be coming into realization that the opioid crisis is here and the damage is catastrophic, gauged against the devastating impact on families and communities across the United States. How can we get the message out that addiction is now recognized as a medical, not a criminal problem, and new treatments are on the horizon. How do we protect the population from misusing opioids? An Opioid Crisis Summit featuring national leaders who are involved in the day to day efforts to fight this opiate crisis on all levels, including Ohio Lieutenant Governor Mary Taylor, Dr. Rahul Gupta, West Virginia Director of Public Health and others who are involved in providing real time solutions to the opiate epidemic as well as treating physicians and legal professionals who are active in offering solutions.

How did the opioid crisis happen?

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive. Opioid overdose rates began to increase. In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.1That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder (not mutually exclusive).

What do we know about the opioid crisis?

An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.

About 80 percent of people who use heroin first misused prescription opioids.

Opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states.

The Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017.

Opioid overdoses in large cities increase by 54 percent in 16 states.

Quarterly rate of suspected opioid overdose, by US region
Source: Centers for Disease Control and Prevention.

This issue has become a public health crisis with devastating consequences including increases in opioid misuse and related overdoses, as well as the rising incidence of neonatal abstinence syndrome due to opioid use and misuse during pregnancy. The increase in injection drug use has also contributed to the spread of infectious diseases including HIV and hepatitis C. As seen throughout the history of medicine, science can be an important part of the solution in resolving such a public health crisis.

The Opioid Crisis Summit Agenda

An unprecedented group of elected officials, political and medical experts, and academic leaders from around the country are set to examine the crisis and offer insight and solutions.

On July 21-22, 2018, the definitive Opioid Crisis Summit presented by Mass Tort Nexus will convene a symposium to present a firsthand account as to the depth and severity of the crisis. The research team at Mass Tort Nexus has brought together influential speakers including the Lieutenant Governor of Ohio, Mary Taylor; State Attorney for Palm Beach County Florida, Dave Aronberg, Esq.; Director of Public Health, State of West Virginia, Rahul Gupta, MD; Executive Director, Novus Medical Detox Centers, Kent Runyon; The Amy Winehouse Project Addiction Recovery Center, Susan Anderson and Blades Williamson; Opioid Crisis Advocate, Stephen Gelfand, MD and Opioid Crisis Expert, John Ray. These speakers are coming together to give our attendees a firsthand look at just how dramatic the impact of the opioid crisis is within our communities.

Summit attendees including attorneys, elected officials and healthcare officials will be giving specific information regarding the legal aspects of the Opioid Crisis as well. This relates to the Opiate Prescription MDL 2804, where hundreds of counties, states and cities across the country have filed lawsuits against the opiate pharmaceutical industry as a whole. This includes key MDL 2804 leadership counsel who will discuss signing of both entity and individual cases, regarding case criteria, damage models and estimated timeframes for settlement. See MDL 2804 Opiate Prescription Litigation US District Court of Ohio, for the National Prescription Opiate Litigation docket information.

This level of professional expertise and real time awareness of the issues regarding the opioid crisis in the United States has never been assembled on a scale such as this and if you are wanting to get the most critical and complete information, please contact someone at Mass Tort Nexus before all seats are taken.

Will Industrial Talc Litigation Become Another Asbestos? The Litigation Is Moving That Way!

By Mark A. York (May 24, 2018)

Is Industrial Talc Litigation The Next Major Mass Tort?

(MASS TORT NEXUS MEDIA) Johnson & Johnson lost another talcum powder cancer trial, when a California jury awarded $4 million in punitive damages on top of $21.7 million in compensatory damages on Wednesday May 23, 2018 to Joanne Anderson and her husband, Ms. Anderson is a 68-year-old woman who sued J&J alleging that he cancer was caused by asbestos in the company’s baby powder. The case is Anderson v. Borg Warner Corp., BC 666513, California Superior Court, Los Angeles County (West Covina).

The jury found that J&J (JNJ.N), was 67 percent responsible for her mesothelioma, a cancer linked to asbestos exposure. Anderson’s lawyers said she was exposed to baby powder laced with the carcinogen when she used it on her children and while bowling.

The verdict against J&J was linked to company documents produced in the trial, “When jurors are given the opportunity to see internal documents and conduct of J&J — things the FDA and government haven’t seen — there is only one choice in how to rule.” According to Chris Panatier, plaintiffs’ lawyer.

Anderson and her husband had sued J&J, a unit of Imerys SA (IMTP.PA), Cyprus Amax Minerals, a unit of Brenntag (BNRGn.DE), Honeywell International (HON.N) and other local talc suppliers, which are now becoming targets more and more in the emerging talc litigation exploding across the country.

J&J’s lawyers have stated that Anderson’s mesothelioma may not have been caused by asbestos in talc, but could have occurred “spontaneously.’’ They also said the woman had a family history of lung and breast cancer. Even though there has been ample evidence shown in court after court, both state and federal that J&J’s talcum powder products are known to be cancer causing. J&J and others have been diligent in suppressing the research and scientific studies showing the cancer links, going so far as to pay “ghost writers” to submit company sponsored “talc is a good product” papers as legitimate scientific materials to recognize medical journals. This conduct dates back to at least the mid-10970’2 when internal J&J consultants working on Talc R&D projects raised red flags on the dangers of talc and the link to cancer.

Hiding Data That Showed Potential Dangers: The standard complaints utilized in the prior trial allege that J&J knew about the risks of ovarian cancer as early as 1971. The complaints allege that “nearly all” of 23 known epidemiologic studies on cosmetic talc reported an associated risk with ovarian cancer, and assert alleged instances in which J&J “knowingly released false information” about the safety of talc in coordination with the Cosmetic Toiletry and Fragrance Association. Media reports suggest that, in post-trial interviews, jurors indicated that these allegations were part of the motivation for the large punitive damages award.

This is the second jury in less than two months to conclude J&J sold its iconic baby powder knowing it contained at least trace amounts of asbestos and posed a cancer risk to users. In April, jurors in J&J’s hometown of New Brunswick, New Jersey, ordered the company and a unit of Imerys SA, a talc supplier, to pay a total of $117 million to a banker who showed his cancer was tied to baby powder use. See For J&J $37 Million Talcum Powder Mesothelioma Verdict—Add $80 Million In Punitive Damages.

Litigation over J&J’s baby powder is accelerating. The company is facing claims by more than 9,000 plaintiffs, primarily connecting talc to ovarian cancer, according to a May 1 securities filing. J&J didn’t break out the number of ovarian cancer cases versus the number of mesothelioma cases allegedly tied to talc. See Johnson & Johnson Talcum Powder Litigation MDL 2738 (USDC New Jersey).

In MDL 2738 J&J is facing more than 6,000 cases claiming its baby powder caused ovarian cancer, but the talc litigation has taken a new focus in recent months with plaintiffs claiming the widely used product causes mesothelioma due to alleged asbestos contamination. These casese are being in in US District Court of New Jersey, in front of Judge Freda Wolfson, who has not been perceived as a plaintiff friendly judge so far. But science is science and as more of the data is released and becomes accepted, J&J’s home court advantage in New Jersey courts will continue to

J&J, talc supplier Imerys and retail seller incuding Rite-Aid pharmacy (RAD.N) are currently facing similar claims in a trial underway in South Carolina over asbestos talc allegations.

Anderson argued she used J&J’s talc products on her children in the 1970s and on herself in the 1980s and 1990s when she would powder her hands and feet while bowling. She claimed at one point, she went through two bottles a month.

Notable Cosmetic Talc/Asbestos Contamination Verdicts

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the J & J cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

Talc History

There are two types of talc: industrial talc which is used most frequently in rubber, plastics and ceramics; and cosmetic talc which is of a higher grade and is used in conjunction with products that involve direct human exposures such as cosmetics, pharmaceuticals and food additives.

Talc manufacturers and companies that have incorporated talc into their products have been, and continue to be, sued. Industrial talc defendants have been involved in litigation for decades. In lawsuits involving industrial talc, plaintiffs generally allege that the talc is contaminated with asbestos. The injuries alleged are mesothelioma, lung cancer and asbestosis. To date, there have been no claims against industrial talc defendants alleging that asbestos in the talc caused ovarian cancer. Industrial talc defendants have aggressively defended the cases and, although suffering some adverse verdicts, they won more cases than they have lost. However, will thousands of new industrial talc claims result in acceptance of litigation and pressure to settle as a suddenly arising “cost of doing business’, such as the view taken by pharmaceutical and medical device manufacturers who incorporate “litigation costs” into corporate filings and simply classify it as an expense of doing business?

Cosmetic talc cases fall into two distinct categories: 1) cosmetic talc alleged to cause ovarian cancer; and 2) cosmetic talc alleged to cause mesothelioma. The J & J verdicts were ovarian cancer cases. There was no claim that the talc was contaminated with asbestos.

While the J & J St. Louis verdicts received significant attention in the national media, cases alleging that asbestos-containing cosmetic talc caused an asbestos-related disease such mesothelioma have been percolating, and some recent notable verdicts have been obtained. In 2015, a Los Angeles jury awarded $13M to a woman who alleged talcum powder sold by Colgate-Palmolive was contaminated with asbestos causing her to contract mesothelioma. These cases, if they emerge as viable litigation, could make cosmetic talc defendants targets by substituting them for insolvent asbestos defendants and anyone else who may be named, which would present an extreme and unforeseen threat to cosmetic talc defendants and affiliated industry.

Cosmetic Talc Litigation – Ovarian Cancer

Cases alleging injury from cosmetic talc are relatively new, as best exemplified by the recent high-profile J & J verdicts. These cases did not depend on asbestos contamination, nor did they allege mesothelioma. Instead, they alleged that talc itself causes ovarian cancer. The ovarian cancer talc cases indeed represent an entirely new class of toxic product liability litigation. The approximately 14,000 ovarian cancer deaths a year, in conjunction with the widespread use of talc in everyday products such as baby powder, renders these cases a serious threat to certain defendants and their insurers.
According to the National Institute of Health, there are 22,280 new ovarian cancer diagnoses each year in the U.S. and 14,240 women die of the disease every year. This is seven times the number of annual mesothelioma diagnoses.

The American Cancer Society estimates that there are only 3,000 new mesothelioma diagnoses a year, with mesothelioma lawsuit filings being stable and not increasing. Like any other business, plaintiffs’ firms are always looking to maintain and grow revenue. Litigation against cosmetic talc defendants alleging ovarian cancer offers a way to substantially increase their bottom line. Indeed, “do you have ovarian cancer?” and “did you use talcum powder?” ads are commonplace on television.

Because everyone can credibly claim exposure to cosmetic talc, the primary issue that will be litigated is the science underlying the causal connection between talc exposure and ovarian cancer. While plaintiffs prevailed in the St. Louis actions, Imerys Talc and J & J persuaded a New Jersey trial court in 2016 to dismiss with prejudice two ovarian cancer cases after granting their motions to bar expert testimony due to inadequate science supporting their opinions. Apparently pressing their advantage, the defendants persuaded the federal talc MDL in New Jersey to conduct a “science day” in which the litigants would attempt to generally demonstrate that cosmetic talc does or does not cause ovarian cancer. The plaintiffs’ bar quickly responded with their own proposed “science day” in California state court, presumably where they perceive a jurisdictional advantage. The “science” of whether cosmetic talc causes ovarian cancer will be the field of battle on which the sustainability of these claims will live or die.

The sustainability of ovarian cancer talc cases will depend on how the courts resolve the science questions surrounding causation. This will depend in large part on the plaintiffs’ bar’s ability to persuade courts outside jurisdictions traditionally favorable to asbestos claimants of the merit of their claims.

Cosmetic Talc Cases Alleging Asbestos Contamination

In addition to the emergence of ovarian cancer cases, cosmetic talc defendants are also at risk of becoming responsible for mesothelioma cases alleging that their products were contaminated with asbestos. If plaintiffs can meet their burden of proving asbestos contamination in their products, the issue of product identification will largely be moot due to the ubiquitous use of talc in everyday products to which any plaintiff can presumably credibly claim exposure.

Allegations of asbestos contamination in talc have a long and disputed history. The FDA launched an investigation in 2010 based on reports that talc from South Korea and China contained asbestos. After extensive testing of various U.S. consumer products, the FDA found no asbestos contamination in the products. However, it described its results as inconclusive and only “informative” because it was unable to secure samples from all of the common talc suppliers.

The issue of whether cosmetic talc is contaminated by asbestos is disputed by the plaintiffs’ bar. The cosmetic talc defendants present an attractive target, especially given the declining pool of solvent asbestos defendants. In addition, while mesothelioma case filings have been relatively flat, the expected decline of mesothelioma claims has failed to emerge.

If mesothelioma cases do trend upward, plaintiffs’ lawyers will have additional incentive to identify new solvent defendants to satisfy the potential liabilities. Cosmetic talc defendants, generally not burdened by years of asbestos liabilities, make attractive defendants. In addition, because the traditional asbestos defendants that used and sold asbestos products have gone bankrupt, plaintiffs’ lawyers have increasingly struggled to demonstrate proximate cause against individual defendants and have been forced to make ever-more tenuous arguments that even de minimus exposures to asbestos caused their clients’ mesothelioma. The widespread use of cosmetic talc overcomes most traditional product identification, proximate cause defenses. Instead, the principal issue becomes only whether a particular product was contaminated with asbestos.
The plaintiffs’ bar will attempt to meet its burden of demonstrating asbestos contamination in cosmetic talc by arguing that traditional testing methods are not precise enough to detect it at low levels and that there is no safe level of asbestos exposure. In previous cases, plaintiffs have employed experts to challenge defendants that maintained talc samples. As these cases are being litigated in the same jurisdictions that handle most asbestos cases, these allegations will be difficult for defendants to rebut.

Question: Will industrial and cosmetic “personal care” products made with talcum powder and the emerging confirmed links to “asbestos” and “mesothelioma” become the new long term mass tort resulting in thousands of complaints against nontraditional and unsuspecting defendants? Such as the Los Angeles County, California Superior Court lawsuits where a 2015 “cosmetic talc” trial resulted in an $18 million verdict award based on “cosmetic talc exposure in a barbershop” against Old Spice, Clubman, Kings Men and Mennen Shave Talc,as well as a prior 2015 trial verdict of $13 million against Colgate-Palmolive for exposure to talc in its baby powder.

(Mass Tort Nexus Media) Litigation against OxyContin maker Purdue Pharma LP and the rest of the Opioid Big Pharma industry just jumped significantly, as six more states have filed lawsuits against Purdue Pharma, et al. The ongoing allegations against the opioid pharmaceutical industry as a whole, where numerous governmental entities from across the country have asserted that the opiate makers have fueled a national opioid crisis. This is primarily based on corporate boardroom designed deceptive opioid marketing campaigns, designed to sell prescription opioids, and minimize the previously well-known medical risks, including addiction and overdose, while generating billions of dollars in sales.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

State attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee assert that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

Teva, in a statement, emphasized the importance of safely using opioids, while AmerisourceBergen said it was committed to collaborating with all stakeholders to combat opioid abuse.

The Healthcare Distribution Alliance, an umbrella group for drug distributors, said in a statement that accusations that distributors were responsible for the abuse of opioid prescriptions defied common sense and lacked understanding of the pharmaceutical supply chain.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small. Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

THE SACKLERS AND PURDUE

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country. At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

PURDUE-OXYCONTIN HISTORY

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What’s more, Purdue Pharma’s patent for the original OxyContin formula didn’t expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

OxyContin’s ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors’ offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn’t make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?

During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

“FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

Former President Bill Clinton pulled no punches as he focused directly on the opiate issues “Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game rests, which is one of the prime issues of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered. Clinton further commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

RURAL vs. BIG CITY OPIATES

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these states, with West Virginia numbers being, 780 million painkillers prescribed in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a point where Opiate Big Pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to assign a financial penalty for the alleged corporate opioid abuses.

FDA Failed to Cite Opioid Big Pharma

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

As the Opioid litigation expands across the country in both state and federal courtrooms, it remains to be seen if the anticipated payouts will surpass the $200 billion payday for governments in the 1998 Big Tobacco Litigation settlement.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

New Jersey State Court MCL Designations: Is NJ the emerging state court mass tort venue for lawsuits against Big Pharma?

By Mark A. York (May 11, 2018)

(Mass Tort Nexus Media) In late 2017 plaintiffs and defendants in the Abilify litigation in New Jersey state court moved to have the litigation designated as a multicounty litigation (MCL) on December 27, 2017 and which was approved as an MCL on May 9, 2018, see links below for both court filings.

The New Jersey judiciary site provides multicounty litigation docket information where you will see there are more MCL dockets that parallel existing federal MDL’s being brought in Big Pharma’s backyard. These multicounty litigations involve large numbers of claims that are associated with pharmaceuticals and medical devices based in New Jersey, and there appears to be an emerging consensus that confronting J&J, Sanofi and others in their home state venue is now a very viable litigation option for mass tort firms across the country. The recently consolidated Abilify MCL is a prime example, as is the pending Taxotere MCL application.

There were nearly 50 Abilify cases filed in Bergen County in New Jersey Superior Court, with that number expected to rise over the next few months, with Superior Court Judge James DeLuca having been the initial judge handling the docket, both plaintiff and defense had agreed that the cases should remain with Judge DeLuca. However, the May 7, 2018 order designated Superior court Judge Nelson C. Johnson and the Atlantic county court as the Abilify New Jersey MCL venue, Abilify New Jersey MCL Designation Atlantic County May 7, 2018.

The motion for MCL designation was filed to ensure that any Abilify case filed in New Jersey will be transferred into the designated state court venue and remain there. There is already a multidistrict litigation (MDL) designation in the Abilify federal litigation, which is consolidated in Northern District of Florida, where the three upcoming bellwether trial were just settled, as well as pending “global settlement order, see Abilify MDL 2734 Global Settlement Order, where Judge Casey Rodgers ordered the parties to reach an agreement within 120 days of the May 1, 2018 order entry date. The MDL for Abilify was consolidated in October 2016, before U.S. District Judge M. Casey Rodgers.

NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts, Ethicon Hernia Mesh Litigation MCL Notice – New Jersey State Court April 11, 2018. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

As a growing number of hernia mesh lawsuits continue to be filed against Johnson & Johnson and it’s Ethicon subsidiary in New Jersey state court, each involving complications allegedly caused by the design of multi-layered patch products sold in recent years, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings.

On April 11, Glenn A. Grant, acting administrative director of New Jersey state courts, issued a Notice To The Bar (PDF), indicating that the state Supreme Court has received an application to create a multicounty litigation (MCL) for all product liability lawsuits over Ethicon multi-layered hernia mesh.

TAXOTERE EMERGING MCL

The most recent MCL application to be filed and listed by the New Jersey Courts is the Taxotere (docetaxel) cancer chemotherapy drug litigation against Sanofi-Aventis US, Sandoz, Inc. and Actavis, Inc with the MCL Notice posted on April 11, 2018 see Taxotere New Jersey MCL Notice To The Bar April 11, 2018.

How the New Jersey state court Taxotere MCL compares to the Taxotere MDL 2740 remains to be seen, but the New Jersey based pharmaceutical giants are now being forced to address mass torts more and more often in their home state courts, which previously was perceived as a venue of last resort for many plaintiff firms across the country.

With these three newest mass torts emerging in New Jersey state courts, along with the many pre-existing MCL’s that have been very successful there, will New Jersey now be considered the “go to” venue for filing litigation against Big PharMa?

“TOTAL VERDICT OF $68 MILLION IN SYNTHETIC SURGICAL MESH TRIAL”

Mark A. York (April 18, 2018)

SYNTHETIC MESH COMPANIES FACING THOUSAND OF LAWSUITS

(MASS TORT NEXUS MEDIA) C.R. Bard, Inc. was ordered to pay an additional $35 million in punitive damages, added to the $33 million the jury initially award for a total of verdict of $68 million in the first Transvaginal Mesh trial for Bard in New Jersey state court. Plaintiff Mary McGinnis was successful in her claims that Bard’s synthetic vaginal mesh implants are defective, asserting that Bard defectively designed the product, ignored warnings and related FDA notices about the numerous adverse events related to their synthetic surgical mesh products.

Bard, a subsidiary of global medical supplier Becton-Dickinson of Franklin Lakes, says it will appeal the verdict. In a statement, the company said McGinnis knew of the inherent risks in having the vaginal implants. This case docket can be found under Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The punitive damage award was added after the initial $33 million verdict was returned and the judge set a hearing to address the punitive damages award. The jury decided that there were grounds to award plaintiff Mary McGinnis and her husband the large verdict based on trial testimony and evidence that Bard was aware of the mesh product dangers and chose to ignore the thousands of adverse events reported related to post-surgery complications claimed by women across the country.

The Bard synthetic mesh products are designed to provide pelvic support for any number of medical issues primarily affecting women, with synthetic mesh recognized as often causing major medical complications and leaving patients in permanent pain. The jury held the company liable for two products that McGinnis had implanted in March of 2009: an Avaulta Solo mesh, and an Align Transobturator and Bard was forced to concede that both products have been taken off the market.

The verdict comes as Murray Hill, New Jersey-based Bard is pushing to a flood of litigation its surgical mesh implants , which have been criticized by women for damaging internal and often affecting or stopping normal sex lives. Bard has settled more than 13,000 cases since 2014, and as of September 2017, the company still faced more than 3,000 suits over allegedly defective synthetic mesh devices still in litigation. Those cases are part of the Bard-TVM-Litigation-MDL-2187 Briefcase, in front of Judge Goodwin, US District Court of West Virginia. While Bard still faces another 150 lawsuits in New Jersey state court, which previously had been perceived as a favorable home court legal venue by the company.

McGinnis alleged Bard’s Avaulta and Align implants shrank after being implanted, causing nerve damage and leaving her unable to engage in sexual activity and that she was forced to undergo four surgeries in attempts to remove all the mesh from her body.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market.J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin. Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Bard has been accused in many lawsuits of using a form of polypropylene mesh in the devices, that their mesh supplier and manufacturer had warned wasn’t suitable for human implantation. Bard officials countered that the mesh was a safe substance from which to make the inserts, ignoring the safety sheet warning issued by the polypropylene mesh product maker.

Last year, C.R. Bard was acquired by medical-device company Becton, Dickinson & Co. $24 billion, combining two of the world’s biggest health-care suppliers. How the thousands of remaining mesh lawsuits affect the company business model and potentially moves them towards serious settlement discussions remains to be seen.

“New Jersey State Court Opens Ethicon Hernia Mesh Consolidation”

Mark A. York (April 17, 2018)

(MASS TORT NEXUS MEDIA) Ethicon’s Pelvic Repair System litigation also known as Transvaginal Mesh (TVM) litigation, (see Mass Tort Nexus Ethicon TVM MDL 2327 Briefcase) and the more recent hernia mesh legal filings, are the latest in a series of ongoing legal battles facing Johnson & Johnson and its Ethicon subsidiary. Ethicon is facing over 50,000 mesh lawsuits in state and federal courts across the country where plaintiffs have filed suits over their synthetic mesh surgical implants. The numbers are increasing daily as the TVM plaintiffs are being joined by plaintiffs filing “hernia mesh” lawsuits, where the allegations are very similar to claims asserting that J&J’s failed to warn and choosing to ignore the thousands of FDA filed adverse events related to its hernia mesh products.

EMERGING NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

Ethicon TVM litigation has been underway for close to six years in MDL 2327, (MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation court link) currently pending in the U.S. District Court in West Virginia, where U.S. District Judge Joseph Goodwin is also overseeing seven other multidistrict litigations (MDLs) established for cases against different manufacturers. When you add in other synthetic mesh manufacturer lawsuits besides J&J, there are more than 100,000 mesh lawsuits pending against Ethicon and other manufacturers, including Boston Scientific, C.R. Bard, American Medical Systems (AMS) acquired by Endo, Coloplast, Cook Medical, Neomedic and others.

Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Only American Medical Systems, Inc has resolved substantially all of their claims over their mesh products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.

PRIOR MESH SETTLEMENTS

While manufacturers have had some success in defending the safety of the products in a handful of cases, most of the claims that have gone before a jury so far have resulted in substantial damage awards, suggesting that TVM settlements will likely cost the companies several billion dollars. There have been settlements by some mesh makers including End International, Inc. on behalf of American Medical Systems, Inc, where Endo agreed to pay $775 million in August 2017 to resolve the remaining cases, where there had been over 22,000 lawsuits filed over its vaginal mesh implants. They had previously agreed to a $400 million settlement of more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. This has been part of Endo’s decision to exit “substantially all” the remaining lawsuits against its AMS unit, with the $400 million being in addition to $1.2 billion previously pledged by Endo to cover mesh litigation. Including its $830 million settlement to resolve thousands of mesh lawsuits (~40,000 per case) in May 2014. That settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny.

ETHICON TRIAL VERDICTS

Although Ethicon attempts to defer blame and causation for the often life altering medical conditions that occur post mesh implant surgery, they are often found liable at trial with verdicts being anywhere from $1.5 million to more than $100 million and often include major punitive damages. The punitive damages, which are designed to punish Ethicon for conducting its business with malice towards women who were implanted with the products, finding that the company knew that the synthetic mesh products caused severe complications, but failed to warn the medical community.

With Ethicon (Johnson & Johnson) facing more vaginal mesh lawsuits than any other manufacturer. Here are trial verdicts from lawsuits that have resulted in major losses for Ethicon/J&J again and again:

In March 2018, a jury in Indiana awarded $35 millionto Barbara and Anton Kaiser. They’d sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. They awarded her $10 million in damages and hit Ethicon with $25 million in punitive damages.

In December 2017, a Bergen County, NJ jury awarded$15 million to Elizabeth Hrymoc. Ms. Hrymoc said she received a defective Prolift mesh implant in 2008, which left her in such pain that she had to have it removed and replaced. She cried as the jury announced their verdict.

In September 2017, a Philadelphia jury awarded $57.1 millionto Ella Ebaugh, who says she suffered chronic pain and incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ms. Ebaugh says she required three surgeries to remove the mesh. Ethicon vowed to appeal.

In April 2017, a Philadelphia jury awarded $20 millionto a woman who claimed she was in constant pain because of her TVT-Secur transvaginal mesh, a product of Johnson & Johnson subsidiary Ethicon. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.

$13.5 million verdict awarded to Sharon Carlino of New Jersey in February 2016. According to the lawsuit, Carlino received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence and it left her with constant pain and discomfort. Two surgical attempts to fix the device did not rid her of pain. $10 million of the verdict came in the form of punitive damages. The jury said that Carlino’s doctor would not have used the Ethicon mesh had the device risks been known.

$4.4 million jury award to Florida resident Tessa Taylor in February 2016. The jury found that ObTape sling (made by J&J subsidiary Mentor) caused Taylor’s back pain, bladder pain, and difficulty urinating over a 7 year period. Taylor received the mesh to treat urinary incontinence, but she was re-diagnosed with the condition in spite of the device. $4 million of the verdict was for punitive damages to “discourage others from behaving in a similar way.”

J&J agreed to pay $120 million to settle 2,000-3,000 mesh lawsuitsin January 2016. The settlement marked the first serious attempt by J&J to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still faced more than 42,000 mesh cases.

$5 millionsettlement reached in September with plaintiff Pamela Wicker, implanted with Ethicon’s Prolift mesh device. Wicker claims that Prolift eroded inside of her and necessitated numerous surgeries to remove the device. A law professor said that the large settlement showed the costs of dealing with mesh litigation would be a lot higher than expected.

$5.7 millionverdict awarded to Coleen Perry in March 2015 by a California jury. Perry was implanted with the J&J/Ethicon TVT Abbrevo and says she expects to have pain the rest of her life. The jury found that the TVT Abbrevo has design problems and that Ethicon failed to warn about potential health risks. The verdict included $5 million in punitive damages for conduct that amounted to “malice.”

Two confidential settlementsinvolving 115 mesh victims were reached in January 2015. One of the settlements resolved 4 cases in Missouri over Ethicon’s Prolift mesh device and the other resolved 111 cases in Georgia over the ObTape Transobturator Sling (made by J&J subsidiary Mentor). The Missouri women claimed that the mesh in Ethicon’s Prolift insert shrinks and damages organs, causing constant pain and making sexual intercourse difficult, while the Georgia women alleged that ObTape causes permanent injuries.

$3.25 millionverdict awarded to plaintiff Jo Husky over the J&J/Ethicon Gynecare TVT-O mesh device. The verdict was reached by a West Virginia jury in September 2014 following a two-week trial. Jurors found that the TVT-O was faulty and that Ethicon failed to warn of side effects.

$1.2 millionverdict awarded to Linda Batiste, implanted with the Gynecare TVT Obturator (TVT-O) mesh sling (made by J&J unit Ethicon) in April 2013. The jury concluded that the device’s design was flawed.

$11.1 millionverdict (including $3.35 million in compensation and $7.76 million in punitive damages) awarded to Linda Gross of South Dakota, who was implanted with J&J’s Gynecare Prolift vaginal mesh device. A New Jersey jury reached the verdict in February 2013, saying that J&J fraudulently misled Gross about device risks.

ETHICON MESH LITIGATION

Judge Goodwin is overseeing coordinated pretrial proceedings for all federal vaginal mesh lawsuits, as the cases involve nearly identical allegations that the products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women are defectively designed and can cause severe and deforming complications, including infections, puncturing organs and eroding through the vagina.

The MDLs were established for cases against each manufacturer to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts. However, as hundreds of cases become “trial ready”, and manufacturers continue to make little progress in settling claims, Judge Goodwin faces the prospect of remanding large numbers of lawsuits back to U.S. District courts nationwide for individual trials, which could take decades to complete.

Plaintiff complaints against Ethicon all consistently assert that Ethicon was and is aware of the dangers posed by their synthetic mesh products, and choose to ignore the thousands of adverse event reports filed with the FDA as well as the fact that more than 50,000 plaintiffs have filed lawsuits over Ethicon synthetic mesh implants. The legal claims assert injuries due to the defective design of the most every synthetic mesh product made by Ethicon regarding its vaginal mesh, including mesh erosion, mesh contraction, inflammation, pain during sexual intercourse, urinary incontinence, chronic pain, and recurring prolapse of organs.

As a result of the post surgical complications, plaintiffs have been known to undergo as many as four operations to have the mesh removed, often resulting in massive levels of pain as well as financial impact of repeated surgeries and rehabilitation. There are many instances where the the surgeons were unable to remove all the mesh due to the mesh adhesion to internal organs and surfaces within the body that were never intended as a post surgical complication.

While the outcome of the MDL cases and other trials are not binding on other cases in the vaginal mesh litigation, Ethicon and its parent Johnson & Johnson should gauge how juries have responded to certain evidence and testimony via recent major trial verdicts in most every mesh trial they’ve faced in both federal and state courts. How Ethicon counsel views the recent trial verdicts and the impact on the thousands of other cases they face, and the potential for the trial results to be repeated throughout these cases, would seem to have an impact on J&J’s views of starting substantive settlement negotiations. To date, this has not been a significant part of the Johnson & Johnson legal business strategy, potentially resulting in an ongoing windfall for the thousands of plaintiffs for years to come.

(MASS TORT NEXUS MEDIA) In another win for plaintiffs, a jury in Bergen County, New Jersey awarded plaintiff Mary McGinnis $23 million and her husband Thomas, an additional $10 million in actual damages, with a hearing taking place today on how much in punitive damages will be be added. This $33 million verdict in New Jersey state court, where defendant C.R. Bard is headquartered, closely follows the $117 million verdict of last week against another New Jersey company, Johnson & Johnson in a baby powder trial. This was the first C. R. Bard case to go to trial in the Bard consolidated New Jersey state court docket, where Bard is facing hundreds of additional lawsuits over its defective pelvic mesh implants, also known as Transvaginal Mesh or TVM.

The jury directed the company to pay the $33 million in compensatory damages over claims the business knew its pelvic mesh products were unsafe and failed to warn doctors about potential risks related to devices that caused a woman debilitating pain and related inability to enjoy life as she did prior to the surgical implant of the synthetic mesh device. Bard and others makers of both TVM and hernia mesh products are under highly increased scrutiny and being hot with major trial verdicts over claims they ignored the dangers of implanting synthetic mesh products, primarily made from polypropylene, the same product most fishing line is made from, into the human body. This case docket can be found under- Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The jury took less than a day to decide on the verdict following the four-week trial, after finding that Bard was responsible for a defective design of the Avaulta mesh product and failure to warn doctors or consumers of the defective design. . Of note is that Bard had removed the Avaulta mesh line from the market by 2016.

The jury found that Bard’s Avaulta and Align synthetic mesh products, which were implanted to treat McGinnis’s bladder prolapse and stress urinary incontinence were defectively designed and caused incapacitating injuries as well as impacting her relationship with her husband. Bard claimed repeatedly that they tested Avaulta extensively as well as their other mesh products, and Mrs. McGinnis’ unrelated medical conditions caused her injuries

Hearings over punitive damages and how much they should be are scheduled to start this morning. Bard is probably keeping in mind the $80 million in punitive damages awarded last week in a similar state court punitive damages hearing in the J&J talcum powder cancer trial in New Brunswick, which is less than 50 miles from the Bergen County court.

Bard has historically been hit with ongoing verdicts over its synthetic mesh line of products in trial across the country, as far back as 2012 where a previous Avaulta mesh trial in California state court ended in a $5.5 million verdict and in a 2013 West Virginia federal court trial, a verdict was returned for $2 million verdict against Bard and its Avaulta mesh.

TVM MESH IS SUBJECT TO MAJOR LITIGATION

Surgical Mesh Makers Facing Litigation

Major litigation against CR. Bard/Davol, Ethicon (J&J), Boston Scientific and other surgical mesh manufacturers has been ongoing for few years in both federal and state courts and will continue into the foreseeable future, based on the hundreds of thousands of synthetic mesh implants used in surgical procedures in the United States over the last 15 years.

Bard has been known to settle mesh cases, in the Wise v. Bard, bellwether case selection, that was set for trial back on February 18, 2015, settled a week before the trail start date for a confidential amount. The Wise lawsuit was part of the Bard MDL 2187, see Bard-TVM-Litigation-MDL-2187 Briefcase, where thousands of lawsuits are still pending against C.R. Bard, additionally there are other MDL’s where every other synthetic surgical mesh manufacturer in the US marketplace is facing more than 50 thousand lawsuits over their synthetic mesh surgical products.” See Ethicon (J&J) Pelvic Mesh Litigation MDL-2327-TVM Briefcase.

OTHER TVM MESH VERDICTS

There were $26.7 million and $18.5 million mesh verdicts against Boston Scientific see Boston-Scientific-TVM-Litigation-MDL-2362 Briefcase, in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014, a Charleston, West Virginia jury awarded $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include:

Transvaginal Mesh Adverse Events

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement.

Complications and Adverse Events Include:

erosion through the vaginal tissue

mesh contraction

mesh extrusion

inflammation

fistula

infection and abscess

pain

blood loss

chronic and acute nerve damage

pudendal nerve damage

pelvic floor damage

scar tissue

chronic pelvic pain

urinary problems and/or incontinence

recurrence of prolapse

bowel, bladder, and blood vessel perforation

dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications.

In July 1, 2012, Bard stopped selling the Avaulta Meshin the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrewfour mesh products from the US Market, including its controversialGynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of lifeover other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

>Federal Judge Dan Polster has ordered the start of formal settlement talks as the way to begin the Opiate Rx MDL 2804, he’s entered a settlement gag order and strongly suggesting the parties move ahead in this area or he will be forced “let both sides loose on each other and the government via wide open discovery” including access to the FDA and DEA files. The fate of multidistrict litigation over the opioid crisis now rests heavily with 18 plaintiff and defense counsel who’ve been tasked with negotiating a settlement in the historic case. The negotiators, chosen earlier this month, are from two camps: seven attorneys representing local governments that assert grievous financial harm from the opioid crisis, and 11 attorneys representing opioid manufacturers and distributors. Their assignment is daunting: broker a quick and meaningful deal that earmarks money for all parties who’ve been affected by the flood of opioids into the US marketplace over the last 15 years.

Johnson & Johnson Talc Use Will Kill Plaintiff Eventually Per Experts in NJ Talc Trial

>An occupational medicine expert told a New Jersey state court jury this week that a man alleging Johnson & Johnson’s baby powder contains asbestos faces a painful death from mesothelioma, and that the disease was caused by his daily use of J&J’s products. According to plaintiff expert occupational health M.D. Jacqueline Moline, of the Feinstein Institute of Medical Research testified on behalf of plaintiff Stephen Lanzo, to support his claim that J&J’s products, including its baby powder, contained the asbestos that caused his mesothelioma. Earlier this week, another plaintiff expert, William Longo, an electron microscopist told jurors Tuesday that he found asbestos in more than half of the 32 samples of Johnson & Johnson talcum powder products he had examined during a trial alleging that using J&J talc caused him to develop mesothelioma, In the trials fourth week, Mr. Longo was called to the stand as a materials science and electron microscopy expert to support plaintiff Stephen Longo’s claim that J&J is responsible for his mesothelioma, an asbestos-related disease that is fatal.

>Lynn Hartman, the woman who won a $28 million verdict in December 2017, in the first Philadelphia bellwether trial over injuries linked to the blood thinner Xarelto has argued the Pennsylvania judge Michael Erdos, who threw out her damages award ignored evidence that additional warnings would not have changed her doctor’s decision to prescribe the medication. In a January 9th hearing Judge Erdos ruled for defense on their Motion to Vacate the Judgment on various grounds, and during the same hearing the judge also ruled on plaintiff trial counsel trial misconduct matters, which resulted in various sanctions against certain members of Ms. Hartman’s trial team.

>Several New Jersey counties and unions have filed suits against OxyContin maker Purdue Pharma and other opioid manufacturers, distributors and retailers in New Jersey state courts, which is outside of the Federal MDL Opiate Prescription MDL 280, in the last 30 days, accusing Purdue of sparking the opioid epidemic with deceptive marketing practices that the others eventually adopted. The claims in NJ sate court appear to be a strategic move to provide local governmental entities with a home court advantage versus jumping into the every growing MDL 2804, where Judge Polster has already moved the parties into settlement talks. There are now many other counties and states that have decided to litigate opioid claims in their own state courts versus joining the masses in the federal MDL, how this plays out in the long run remains to be seen. Several county and state court suits originally placed in the Opiate MDL have already been remanded back to state courts by the federal court.

>A Johnson & Johnson unit on Tuesday urged the Pennsylvania Supreme Court to leave standing a recent decision jeopardizing thousands of pending lawsuits by rolling back the clock on when claims of abnormal breast growth allegedly linked to the antipsychotic drug Risperdal began to expire. The justices are weighing whether to hear an appeal of a November ruling from the state’s Superior Court finding that a two-year statute of limitations of Risperdal-related lawsuits, more than 6,600 of which are pending in Philadelphia County, should have started the Statute of Limitations clock, which if upholds the decisions, will cause the dismissal of many of the cases in the Phila court Risperdal docket. J&J has not fared well to date in the Risperdal cases, with verdicts against now reaching the hundreds of millions of dollars and a recent ruling that Punitive damages are now permitted for many cases. J&J’s Janssen R&D division is also facing thousands of suit in the Xarelto litigation also filed in the Phila Court of Common Pleas docket.

>A Pennsylvania appeals court on Tuesday rejected efforts by a Johnson & Johnson unit to challenge expert testimony relied on by jurors in finding that the antipsychotic drug Risperdal had caused a Maryland boy to grow female breast tissue. A three-judge Superior Court panel shot down arguments from Janssen Pharmaceuticals Inc. that Dr. Francesco DeLuca had improperly relied on an 8-year-old photograph to conclude that Nicholas Murray had been suffering from gynecomastia, or the abnormal growth of female breast tissue in males, at the time the drug was prescribed. However the Superior Court panel did rule that the Murray v. Janssen Pharmaceuticals, case would go back to the trial court for further determination as to the jury award cap based on Maryland law, wher the plaintiff resides, and taking into account the recent Superior Court ruling that permits punitive damages in the Risperdal litigation. The Murray trial which was the third case to go to trial in the Risperdal mass tort docket in the Philadelphia Court of Common Pleas. The plaintiff was initially awarded a $1.75 million verdict, which was later reduced by the trial court to $680,000, pursuant to the Maryland statute capping damages. The unanimous panel rejected defendant Janssen Pharmaceutical’s attempt to overturn the verdict and affirmed the trial judge’s decision to limit the jury award based on a Maryland law that caps noneconomic damages. However, citing its decision in a case last month that opened the doors for Risperdal plaintiffs to seek recovery of punitive damages, Judge John Bender remanded the case to the trial court to determine whether plaintiff Nicholas Murray, a Maryland resident, should be allowed to seek punitive damages in the case.

>Drug distributor Cardinal Health has exacerbated the opioid epidemic by filling suspicious drug orders and neglecting to alert the authorities about them, Kentucky’s attorney general claimed in a suit filed Monday in state court. Andy Beshear, lead plaintiff counsel claims Cardinal shipped massive opioid orders throughout Kentucky for years, that were unusually large, frequent and deviated from a past pattern, shunning its own data and “common sense” in favor of profits and market share. Beshear had previously sued McKesson Corp., who along with Cardinal and AmerisourceBergen, distributes 85 percent of the country’s prescription opiates, and are alleged to have engaged in an organized and boardroom acknowledged policy of not reporting massive opiate order increases or failing to accurately track the millions of opiate pills that made their way into so many small towns in the region of Kentucky, West Virginia and Ohio. How the drug distribution monitors at these companies couldn’t recognize that often 2 million plus opioid tablets were being shipped to towns that had populations of less than 2,000 remains as the big question, that nobody at these Fortune 50 companies will admit to or acknowledge was an issue. The lack of oversight and re[porting took place during the last 15 years of record breaking profits where billions of dollars in revenue were collected year in and year out by drug distribution companies.

>Federal Judge Rebecca Pallmeyer enterd CMO No. 13 on February 12, 2018 placing a stay on proceeding in MDL 2272, pending the outcome of the finalization of the settlement discussion and a full resolution of the Zimmer NexGen Knee litigation. Lead counsel in the Zimmer NexGen litigation on Feb. 6 told Judge Pallmeyer, that they have reached an agreement in principle that will potentially resolve all MDL cases and similar cases filed in state court as of Jan. 15, 2018. If approved, the settlement will end seven years of litigation, during which some 300 plaintiffs alleged the engineering changes that Zimmer made to allow a greater degree of flexibility in its NexGen components in fact caused greater stress on the knee implants. The NexGen high-flex components theoretically allow patients to bend their knees by 155 degrees, while standard NexGen components provide for up to 125 degrees of bending, according to the plaintiffs.

The Zimmer NexGen knee replacement system has been on the market, almost half a million people in the US alone have had Zimmer knee implants. However, the Zimmer knee replacement, namely the NexGen CR-Flex Porous Femoral component, has been linked to a variety of problems, from loosening of the implant to failure of the replacement knee, requiring revision surgery, as the plaintiffs in the MDL also allege.

The case is MDL 2272 Re: Zimmer NexGen Knee Implant Products Liability Litigation, (MDL Docket No. 2272, U.S. District Court for the Northern District of Illinois)

(MASS TORT NEXUS MEDIA) On February 13, 2018, the Orange County Superior Court rejected efforts by opioid manufacturers to dismiss a lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney on behalf of the People of the State of California. The lawsuit, filed in May 2014, alleges that the defendants—including opioid manufacturers Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., Endo Health Solutions, Inc., and Actavis PLC—engaged in a deceptive marketing scheme that trivialized the risks of opioids, resulted in rampant over-prescribing, and led to a nationwide epidemic of opioid abuse and addiction.

“The court’s ruling puts an end to years of delay tactics by the defendants,” said Santa Clara County Counsel James R. Williams. “Now we will finally be able to move forward with the litigation and obtain key documents demonstrating the manufacturers’ misconduct. This is a critical step in addressing the opioid crisis that plagues California and the nation, and we will fight to hold opioid manufacturers accountable for their actions.”

STATE COURTS AHEAD OF FEDERAL OPIATE LITIGATION

In addition to the California counties suing in state court there are more than 200 counties from across the country as well as 30 major cities that have filed suits against opioid manufacturers in Opiate Prescription Multidistrict Litigation MDL 2804, pending in the US District Court of Northern Ohio in front of Judge Dan Polster, see Prescription Opiates MDL 2804 Briefcase. In addition to governmental entities, Judge Polster has also permitted unions and hospitals to join in the consolidated opioid litigation against Purdue Pharma, et al. The age of “Profits Before Patients” by Big Pharma may finally have started to come to an end, but it will not occur with very aggressive legal tactics and maneuvering by the opioid makers defense teams.

INSURERS ARE FIGHTING BACK

Earlier this year Travelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

OPIOID RX DRUG MAKERS CHANGING TACTICS

The ruling comes the same week that Purdue Pharma, maker of the opioid OxyContin, announced that it will cut its salesforce in half and stop promoting opioids to doctors. The lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney was among the first lawsuits brought by government officials to hold opioid manufacturers responsible for their role in the opioids crisis. Manufacturers like Purdue now face pressure from hundreds of additional lawsuits nationwide.

The lawsuit was filed on May 21, 2014, against major opioid manufacturers. (People of the State of California v. Purdue Pharma, et al., Orange County Superior Court, Case No. 30-2014-00725287-CU-BT-CXC.) In 2015, defendants moved to stay the lawsuit, and the case was stayed until October 2016, when the court partially lifted the stay to consider defendants’ arguments that the case should be dismissed. The court has now lifted the stay entirely, and its ruling allows the lawsuit to go forward.

UP TO $500 BILLION SETTLEMENT

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

(MASS TORT NEXUS MEDIA) Plaintiffs in the Risperdal litigation, may now seek punitive damages under a recent ruling by the Pennsylvania Superior Court. Previously, plaintiffs were prevented from seeking punitive damages because the laws of New Jersey, applied to the Risperdal cases filed in the Philadelphia Court of Common Pleas, see Risperdal Re: Janssen: Philadelphia Court of Common Pleas. Johnson & Johnson is headquartered in New Jersey, with the courts previously applying those laws which barred punitive damages.

More than 6,000 Risperdal lawsuits in the Philadelphia docket allege Risperdal caused young men and boys to develop a condition called gynecomastia, where female breasts develop in male patients, with J&J’s Janssen Pharmaceuticals failing to warn about the risk.

The three-judge Superior Court panel ruled on January 9, 2018, that plaintiffs in the Philadelphia cases may apply the law of their home state to seek punitive damages, which opens up an entirely new legal avenue for plaintiffs.

Johnson & Johnson stated they were “disappointed in the ruling” and will be considering all options moving forward, while plaintiff counsel commented “This is something we’ve been right about from the beginning and maybe now, once and for all, J&J will recognize they’re facing punitive damages.”

Now that there is a threat of punitive damages, J&J will have to determine long term case strategy, as the punitive awards against J&J in 2016 – 2017 in other mass torts amounted to over eight hundred million dollars, and plaintiffs’ attorneys hope J&J will consider settling the remaining cases.

Plaintiffs have filed more than 6,400 product liability cases resulting from the use of anti-psychotic drug Risperdal in the complex litigation docket of the Philadelphia Court of Common Pleas. Plaintiff lead counsel, Tom Kline of Kline & Specter in Philadelphia, says “stakes in these cases will be raised now that the prospect of punitive damages is in play.”

On Jan. 8, Superior Court Judges Jack A. Panella, Alice Beck Dubow and Kate Ford Elliott ruled that plaintiffs in the Philadelphia-based Risperdal litigation may apply the respective laws of their home states to attempt to obtain punitive damages from Janssen Pharmaceuticals, the developer of Risperdal and a subsidiary of Johnson & Johnson.

“This is a pivotal decision in the Risperdal litigation. The Court found that the trial evidence justified the verdict in plaintiff’s favor. In addition, the stakes in any mass tort are raised when punitive damages are recoverable. This thoughtful and thorough opinion will now provide guidance for the entire litigation moving forward,” Kline said.

J&J and Janssen official statement is “We are disappointed in the Court’s ruling and will consider our options going forward. Contrary to the impression plaintiffs’ attorneys have attempted to create over the course of this litigation, Risperdal (risperidone) is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions,” there was no comment released by Janssen defense counsel.

Currently, most of the 6,400 lawsuits based in the Philadelphia Risperdal docket have been filed by out-of-state plaintiffs, who assert Risperdal causes young males to contract gynecomastia, or the development of female breast tissue, and that Johnson & Johnson failed to adequately warn of these side effects from the drug.

The Superior Court’s new ruling applies across-the-board, as even plaintiffs who have previously received jury verdicts in Risperdal litigation, can now petition the court for new trials or request hearings to enhance verdict awards by adding punitive damages. One prior jury verdict was for more than $70 million and plaintiffs can now request additional punitive damages be awarded.

Before this ruling, seeking of punitive damages in Risperdal cases was prohibited according to New Jersey state law – because Johnson & Johnson is headquartered there.

Mr. Stange used Risperdal for three years during his childhood, for treatment of Tourette’s syndrome, and at the close of the trial, a Philadelphia jury awarded him $500,000, and the recent Superior Court ruling has now upheld plaintiff arguments that an inadequate warning of the gynecomastia risks directly caused his injuries.

According to reports from the Philadelphia Court of Common Pleas, of the suits filed in the first 3 months of 2017, about 80 percent of cases in the Complex Litigation docket, came from out-of-state plaintiffs. With this recent ruling, it would seem logical that the number of Risperdal lawsuits filed in the Philadelphia court, may increase dramatically as the potential verdict award amounts have just risen to unknown numbers at this point.

One explanation for the surge in Risperdal filings can be directed toward defendants Johnson & Johnson, when they decided to cancel tolling agreements on thousands of cases. Knowing this strategy would increase the number of cases filed and the burden on the Court.

Tolling agreements pause the statute of limitations to file a lawsuit, and J&J actions seem to indicate that they wanted more lawsuits, not less, with J&J deciding to cancel the agreement after the $77 million verdict.

To date, eight Risperdal case have gone to trial in Philadelphia, with four juries ruling in favor of the plaintiffs, and J&J getting the other four cases dismissed.

The first case to trial, filed by Austin Pledger of Alabama was heard in 2012, with the jury siding with Pledger, finding J&J and Janssen failed to warn the drug could cause gynecomastia, and the jury awarded $2.5 million to Mr. Pledger.

After two more verdicts of $500,000 and $1.75 million were awarded to plaintiffs, in 2016 a Philadelphia jury handed a landmark verdict of $70 million to Andrew Yount of Tennessee, with. Judge Paula Patrick adding nearly $7 million in additional damages over intentional delays during the legal proceedings.

With the new rules regarding punitive damage, including permitting retroactive claims by successful plaintiffs to now request punitives, Johnson & Johnson/Janssen Pharmaceuticals may need to rethink their long term case strategy, as having a punitive sword hanging over the 6,400 plus remaining cases, should cause defense counsel to re-evaluate their position sooner versus later.